Ammonium Lac 12% Lotion 396gm (otc)
It is used to treat dry, scaly skin.It is used to treat itching caused by dry skin.
Drug Class
Keratolytic, Moisturizer
Pharmacologic Class
Alpha-hydroxy acid (AHA), Humectant
Pregnancy Category
Not assigned (topical OTC, minimal systemic absorption)
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
This lotion contains lactic acid, which is a natural moisturizer that helps to soften and smooth rough, dry, and scaly skin. It works by helping your skin shed dead cells and hold onto moisture, making it feel softer and look healthier.
How to Use This Medicine
Proper Use of This Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. It is essential to use this medication only as directed.
Apply this medication to your skin only, as directed by your doctor. Do not take it by mouth.
Avoid getting the medication in your mouth, nose, or eyes, as it may cause burning.
Wash your hands before and after applying the medication, unless your hand is the area being treated. In that case, do not wash your hand after application.
Clean the affected area before applying the medication and make sure it is dry.
Apply a thin layer of the medication to the affected skin and gently rub it in.
Do not apply the medication to open wounds, cuts, or irritated skin.
Before each use, shake the medication well.
Storage and Disposal
To store and dispose of this medication properly:
Keep it at room temperature.
Store all medications in a safe place, out of the reach of children and pets.
Dispose of unused or expired medications. Do not flush them down the toilet or pour them down the drain unless instructed to do so.
If you have questions about disposing of medications, consult your pharmacist. You may also have access to drug take-back programs in your area.
Missing a Dose
If you miss a dose, follow these steps:
Apply the missed dose as soon as you remember.
If it is close to the time for your next dose, skip the missed dose and resume your regular schedule.
Do not apply two doses at the same time or take extra doses.
To use this medication correctly, follow your doctor's instructions and read all the information provided. It is essential to use this medication only as directed.
Apply this medication to your skin only, as directed by your doctor. Do not take it by mouth.
Avoid getting the medication in your mouth, nose, or eyes, as it may cause burning.
Wash your hands before and after applying the medication, unless your hand is the area being treated. In that case, do not wash your hand after application.
Clean the affected area before applying the medication and make sure it is dry.
Apply a thin layer of the medication to the affected skin and gently rub it in.
Do not apply the medication to open wounds, cuts, or irritated skin.
Before each use, shake the medication well.
Storage and Disposal
To store and dispose of this medication properly:
Keep it at room temperature.
Store all medications in a safe place, out of the reach of children and pets.
Dispose of unused or expired medications. Do not flush them down the toilet or pour them down the drain unless instructed to do so.
If you have questions about disposing of medications, consult your pharmacist. You may also have access to drug take-back programs in your area.
Missing a Dose
If you miss a dose, follow these steps:
Apply the missed dose as soon as you remember.
If it is close to the time for your next dose, skip the missed dose and resume your regular schedule.
Do not apply two doses at the same time or take extra doses.
Lifestyle & Tips
- Apply to clean, dry skin.
- Avoid contact with eyes, lips, and mucous membranes.
- May cause temporary stinging or burning, especially on broken or irritated skin.
- Use sunscreen and protective clothing, as lactic acid can increase sun sensitivity.
- Do not apply to acutely inflamed, broken, or open skin.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
Apply to affected areas twice daily or as directed by a physician.
Condition-Specific Dosing:
xerosis:
Apply to dry, scaly skin areas twice daily.
ichthyosis:
Apply to affected areas twice daily.
Pediatric Dosing
Neonatal:
Not established (consult pediatrician)
Infant:
Not established (consult pediatrician)
Child:
Apply to affected areas twice daily or as directed by a physician. Use with caution on sensitive skin.
Adolescent:
Apply to affected areas twice daily or as directed by a physician.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed (minimal systemic absorption)
Moderate:
No adjustment needed (minimal systemic absorption)
Severe:
No adjustment needed (minimal systemic absorption)
Dialysis:
No specific considerations (minimal systemic absorption)
Hepatic Impairment:
Mild:
No adjustment needed (minimal systemic absorption)
Moderate:
No adjustment needed (minimal systemic absorption)
Severe:
No adjustment needed (minimal systemic absorption)
Pharmacology
Mechanism of Action
Lactic acid is an alpha-hydroxy acid (AHA) that acts as a humectant, attracting and holding water in the skin. It also has keratolytic properties, promoting the shedding of dead skin cells and softening hyperkeratotic areas. Ammonium hydroxide is used to adjust the pH of the lotion, which is important for the stability and efficacy of lactic acid.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption (topical)
Tmax:
Not applicable (minimal systemic absorption)
FoodEffect:
Not applicable (topical)
Distribution:
Vd:
Not applicable (minimal systemic absorption)
ProteinBinding:
Not applicable (minimal systemic absorption)
CnssPenetration:
No (minimal systemic absorption)
Elimination:
HalfLife:
Not applicable (minimal systemic absorption)
Clearance:
Not applicable (minimal systemic absorption)
ExcretionRoute:
Not applicable (minimal systemic absorption)
Unchanged:
Not applicable (minimal systemic absorption)
Pharmacodynamics
OnsetOfAction:
Days to weeks for noticeable improvement in skin texture and hydration.
PeakEffect:
Weeks of consistent use.
DurationOfAction:
Maintained with continued use; effects diminish upon discontinuation.
Confidence:
Medium
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek immediate medical attention:
- Signs of an allergic reaction, such as rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, difficulty breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. Contact your doctor or seek medical help if you experience any of the following side effects or if they persist or bother you:
- Irritation at the site where the medication was applied
- Burning or stinging sensations
- Itching
Note: This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, consult your doctor for advice. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek immediate medical attention:
- Signs of an allergic reaction, such as rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, difficulty breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. Contact your doctor or seek medical help if you experience any of the following side effects or if they persist or bother you:
- Irritation at the site where the medication was applied
- Burning or stinging sensations
- Itching
Note: This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, consult your doctor for advice. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Severe burning
- Stinging that does not subside
- Excessive redness
- Swelling
- Rash
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced as a result of the allergy.
Potential interactions with other medications or health conditions. This drug may interact with other prescription or over-the-counter (OTC) medications, natural products, or vitamins, which could affect its safety and efficacy.
All medications you are currently taking, including prescription and OTC medications, natural products, and vitamins. This information will help your doctor and pharmacist assess potential interactions and ensure safe use.
Any existing health problems, as they may impact the safety and effectiveness of this medication.
To ensure your safety, do not start, stop, or change the dose of any medication without first consulting your doctor. It is crucial to verify that it is safe to take this medication with all your other medications and health conditions.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced as a result of the allergy.
Potential interactions with other medications or health conditions. This drug may interact with other prescription or over-the-counter (OTC) medications, natural products, or vitamins, which could affect its safety and efficacy.
All medications you are currently taking, including prescription and OTC medications, natural products, and vitamins. This information will help your doctor and pharmacist assess potential interactions and ensure safe use.
Any existing health problems, as they may impact the safety and effectiveness of this medication.
To ensure your safety, do not start, stop, or change the dose of any medication without first consulting your doctor. It is crucial to verify that it is safe to take this medication with all your other medications and health conditions.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
To minimize potential side effects, avoid exposing the treated area to sunlight. Additionally, be aware that applying this drug after shaving or on sensitive, irritated, or broken skin may cause burning or stinging sensations.
If you use this medication on your face, you may have a higher risk of experiencing skin irritation. Furthermore, using this drug too frequently can exacerbate your skin condition.
If you are pregnant, planning to become pregnant, or are breastfeeding, it is crucial to discuss the benefits and risks of this medication with your doctor, as this will help determine the best course of action for both you and your baby.
To minimize potential side effects, avoid exposing the treated area to sunlight. Additionally, be aware that applying this drug after shaving or on sensitive, irritated, or broken skin may cause burning or stinging sensations.
If you use this medication on your face, you may have a higher risk of experiencing skin irritation. Furthermore, using this drug too frequently can exacerbate your skin condition.
If you are pregnant, planning to become pregnant, or are breastfeeding, it is crucial to discuss the benefits and risks of this medication with your doctor, as this will help determine the best course of action for both you and your baby.
Overdose Information
Overdose Symptoms:
- Severe local skin irritation (redness, burning, peeling)
- Unlikely to cause systemic symptoms due to minimal absorption.
What to Do:
Wash affected area thoroughly with water. Discontinue use. If irritation persists, seek medical attention. For accidental ingestion, contact a poison control center (e.g., 1-800-222-1222) or emergency services.
Drug Interactions
Moderate Interactions
- Other topical exfoliants (e.g., salicylic acid, retinoids): May increase skin irritation or dryness.
Minor Interactions
- Topical corticosteroids: May alter absorption or efficacy if applied concurrently to the same area.
Monitoring
Routine Monitoring
Skin irritation (redness, burning, stinging)
Frequency: Daily, especially during initial use
Target: Minimal to none
Action Threshold: Persistent or severe irritation; discontinue use and consult physician.
Symptom Monitoring
- Redness
- Burning
- Stinging
- Itching
- Dryness
- Peeling
Special Patient Groups
Pregnancy
Generally considered safe for topical use during pregnancy due to minimal systemic absorption. However, consult a healthcare provider before use.
Trimester-Specific Risks:
First Trimester:
Low risk due to minimal systemic absorption.
Second Trimester:
Low risk due to minimal systemic absorption.
Third Trimester:
Low risk due to minimal systemic absorption.
Lactation
Generally considered safe for use during lactation due to minimal systemic absorption. Avoid applying to areas where the infant may ingest the product.
Infant Risk:
Low risk (L1 - Safest) due to minimal systemic absorption.
Pediatric Use
Generally safe for children, but use with caution on very young children or those with highly sensitive skin. Always consult a pediatrician for use in infants and very young children.
Geriatric Use
Generally safe for geriatric patients. May be beneficial for age-related dry skin. Use with caution on very thin or fragile skin, as it may be more prone to irritation.
Clinical Information
Clinical Pearls
- This lotion is particularly effective for conditions like xerosis (dry skin), ichthyosis, and keratosis pilaris.
- Patients should be advised that initial application may cause mild stinging or burning, which usually subsides with continued use.
- Emphasize the importance of sun protection due to increased sun sensitivity.
- For best results, apply immediately after bathing while skin is still damp to lock in moisture.
Alternative Therapies
- Emollients (e.g., petrolatum, mineral oil)
- Humectants (e.g., glycerin, hyaluronic acid)
- Topical corticosteroids (for inflammatory skin conditions)
- Prescription strength keratolytics
Cost & Coverage
Average Cost:
$15 - $30 per 396gm bottle
Generic Available:
Yes
Insurance Coverage:
OTC (Over-the-Counter), generally not covered by insurance unless prescribed by a physician.
General Drug Facts
If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about this medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.